MAUDE Adverse Event Report: GLAXOSMITHKLINE DUNGARVAN LTD ULTRA COREGA FLAVOR FREE; DENTURE ADHESIVE

Lot Number DE99231

Device Problems Loss of or Failure to Bond (1068); Human-Device Interface Problem (2949)

Patient Problem Cancer (3262)

Event Type  Injury  

Manufacturer Narrative

Report # 3003721894-2019-00043 is associated with (b)(4), ultra corega flavor free.Ultra corega flavor free is marketed as super poligrip in the u.S.

Event Description

Liver cancer [hepatic cancer].Misuse [device used for unapproved schedule].Case description: this case was reported by a consumer via call center representative and described the occurrence of hepatic cancer in a (b)(6) year-old male patient who received double salt dental adhesive cream (ultra corega flavor free) cream (batch number de99231, expiry date july 2021) for product used for unknown indication.This case was associated with a product complaint.Concurrent medical conditions included heart disorder.Concomitant products included spironolactone, furosemide (lasix), bisoprolol fumarate (corbis) and acenocoumarol (sintrom).On an unknown date, the patient started ultra corega flavor free.On an unknown date, an unknown time after starting ultra corega flavor free, the patient experienced hepatic cancer (serious criteria gsk medically significant), device used for unapproved schedule and product complaint.Ultra corega flavor free was continued with no change.On an unknown date, the outcome of the hepatic cancer, device used for unapproved schedule and product complaint were unknown.It was unknown if the reporter considered the hepatic cancer and device used for unapproved schedule to be related to ultra corega flavor free.Additional details: the male consumer had been using ultra corega flavor free since approximately 2 years ago.Due to the product presents with an adhesion problem, he had to use it twice a day, although this was not recommended in the product label (misuse).Furthermore, currently he was diagnosed with liver cancer.The consumer was still using the product.The consumer was under treatment with 2 diuretics per day, in the morning: spironolactone and lasix 40.He took 1 tablet a day of 100 mg and another day, he took 75 mg (did not specify which of both medications).Also, he took one-quarter tablet of sintrom a day.It was unknown if the misuse was intentional or not.

Event Description

Case description: this case was reported by a consumer via call center representative and described the occurrence of hepatic cancer in a 86-year-old male patient who received double salt dental adhesive cream (ultra corega flavor free) cream (batch number: de99231, expiry date july 2021) for product used for unknown indication.This case was associated with a product complaint.Concurrent medical conditions included heart disorder.Concomitant products included spironolactone, furosemide (lasix), bisoprolol fumarate (corbis) and acenocoumarol (sintrom).On an unknown date, the patient started ultra corega flavor free.On an unknown date, an unknown time after starting ultra corega flavor free, the patient experienced hepatic cancer (serious criteria gsk medically significant), device used for unapproved schedule and product complaint.Ultra corega flavor free was continued with no change.On an unknown date, the outcome of the hepatic cancer, device used for unapproved schedule and product complaint were unknown.It was unknown if the reporter considered the hepatic cancer and device used for unapproved schedule to be related to ultra corega flavor free.This report is made by gsk without prejudice and does not imply any admission or liability for the incident or its consequences.Additional details: the male consumer had been using ultra corega flavor free since approximately 2 years ago.Due to the product presents with an adhesion problem he had to use it twice a day, although this was not recommended in the product label (misuse).Furthermore, currently he was diagnosed with liver cancer.The consumer was still using the product.The consumer was under treatment with 2 diuretics per day, in the morning: spironolactone and lasix 40.He took 1 tablet a day of 100 mg and another day, he took 75 mg (did not specify which of both medications).Also, he took one-quarter tablet of sintrom a day.It was unknown if the misuse was intentional or not.Follow up information was received from quality assurance department on 22 feb 2018; the patient received double salt dental adhesive cream (ultra corega flavor free) cream (batch number: dk1463, expiry date 30 sep 2021).Quality assurance analysis revealed the complaint to be unsubstantiated.Upon the receipt of the sample, the batch number and expiration date of the second suspect product were verified.

Manufacturer Narrative

Argus case: (b)(4), ultra corega flavor free.Ultra corega flavor free is marketed as super poligrip in the us.Device evaluation for on february 22nd 2019, the qa department performed the complaint closure for issue: (b)(4).The complaint will be closed as unsubstantiated.No other details provided.

• Brand Name: ULTRA COREGA FLAVOR FREE
• Type of Device: DENTURE ADHESIVE
• Manufacturer (Section D): GLAXOSMITHKLINE DUNGARVAN LTD; dungarvan, waterford ; EI
• MDR Report Key: 8326349
• MDR Text Key: 135876977
• Report Number: 3003721894-2019-00043
• Device Sequence Number: 1
• Product Code: KOT
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial,Followup
• Report Date: 02/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: DE99231
• Initial Date Manufacturer Received: 02/04/2019
• Initial Date FDA Received: 02/11/2019
• Supplement Dates Manufacturer Received: 02/22/2019
• Supplement Dates FDA Received: 03/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CORBIS (BISOPROLOL FUMARATE) TABLET; LASIX (FUROSEMIDE); SINTROM (ACENOCOUMAROL); SPIRONOLACTONE TABLET
• Patient Outcome(s): Other
• Patient Age: 86 YR
• Patient Weight: 73